Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1374853-91-4

Unique Ingredient Identifier: DPT0O3T46P

Background: Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.

Indication: Pembrolizumab is indicated for the following conditions:

For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.

Associated Conditions: Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Associated Therapies: -

Clinical Trials

Pembrolizumab In Combination With Debio 1143 In Pancreatic and Colorectal Advanced/Metastatic Adenocarcinoma

Phase 1

Completed

Conditions: Adenocarcinoma of the Pancreas
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum

Interventions: Drug: Pembrolizumab
Drug: DEBIO1143

First Posted Date: 2019-03-12

Last Posted Date: 2023-02-17

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 54

Registration Number: NCT03871959

Locations: 🇫🇷
Centre Léon Bérard, Lyon, France

Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)

Phase 3

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Placebo

First Posted Date: 2019-03-07

Last Posted Date: 2024-11-14

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 950

Registration Number: NCT03867084

Locations: 🇧🇪
UZ Leuven ( Site 0377), Leuven, Vlaams-Brabant, Belgium
🇺🇸
City of Hope Medical Center ( Site 0027), Duarte, California, United States
🇦🇷
Fundación favaloro para la Docencia e Investigación Médica ( Site 0808), Buenos Aires, Caba, Argentina

and more 246 locations

neoadjuvant_thymic Epithelial Tumor

Phase 2

Conditions: Thymic Epithelial Tumor

Interventions: Drug: pembrolizumab
Radiation: Radiation

First Posted Date: 2019-02-28

Last Posted Date: 2021-03-22

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 40

Registration Number: NCT03858582

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma

Phase 1

Active, not recruiting

Conditions: Metastatic Urothelial Carcinoma
Stage III Bladder Cancer AJCC v8
Stage IV Bladder Cancer AJCC v8
Locally Advanced Urothelial Carcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Drug: Tazemetostat

First Posted Date: 2019-02-26

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT03854474

Locations: 🇺🇸
Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States
🇺🇸
The University of Kansas Cancer Center - Olathe, Olathe, Kansas, United States
🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

and more 31 locations

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: belantamab mafodotin
Drug: Pembrolizumab

First Posted Date: 2019-02-21

Last Posted Date: 2024-04-09

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 41

Registration Number: NCT03848845

Locations: 🇪🇸
GSK Investigational Site, Salamanca, Spain

Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Lung Cancer, Non-Small Cell
Metastatic Squamous Cell Carcinoma
Metastatic Non-Squamous Cell Carcinoma

Interventions: Drug: ADXS-503
Drug: Pembrolizumab

First Posted Date: 2019-02-20

Last Posted Date: 2024-06-04

Lead Sponsor: Advaxis, Inc.

Target Recruit Count: 24

Registration Number: NCT03847519

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Atlantic Health System, Carol G Simon Cancer Center, Morristown, New Jersey, United States
🇺🇸
Illinois CancerCare, P.C., Peoria, Illinois, United States

and more 6 locations

A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer

Phase 1

Completed

Conditions: Non Small Cell Lung Cancer Metastatic
Non Small Cell Lung Cancer
Nonsquamous Nonsmall Cell Neoplasm of Lung
Sensitizing EGFR Gene Mutation

Interventions: Drug: Etrumadenant
Drug: Zimberelimab
Drug: Carboplatin
Drug: Pemetrexed
Drug: Pembrolizumab

First Posted Date: 2019-02-19

Last Posted Date: 2024-12-09

Lead Sponsor: Arcus Biosciences, Inc.

Target Recruit Count: 77

Registration Number: NCT03846310

Locations: 🇰🇷
Chungbuk National University Hospital, Cheongju-si, Korea, Republic of
🇰🇷
Bundang CHA Medical Center, Seongnam-si, Korea, Republic of
🇰🇷
Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

and more 19 locations

Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases

Phase 2

Recruiting

Conditions: Stage IVA Colorectal Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Metastatic Malignant Neoplasm in the Liver
Stage IV Colorectal Cancer AJCC v8